Northside Hospital, Inc.
This is an open-label, Phase 2 study designed to evaluate the safety and efficacy of belumosudil and rituximab as primary treatment of cGVHD.
Inclusion Criteria: * First episode of systemic immunosuppression-requiring cGVHD, defined as classic cGVHD by the NIH consensus criteria (without features or characteristics of aGVHD) * Previously untreated, defined by having received \<10 days of corticosteroids or alternative systemic immunosuppressive agent started specifically for a new diagnosis of cGVHD * KPS \>/= 70% * Adequate hematologic function independent of platelet transfusion and G-CSF for at least 7 days prior to study entry: ANC \>750 cells/mm3; Platelets \>30,000 cells/mm# Exclusion Criteria: * Late persistent or recurren…
200mg PO QD x 24 cycles (28-day cycle)
375mg/m2 IV Q1 week x 4 weeks, then Q3 months x4 doses
Arctuva estimate
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